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Pharmacological Strategies for the Management of Severe Alcohol-associated Hepatitis: A Systematic Review and
Alvi H Islam1, Claudia Alvizuri2, Hailemichael Desalegn3
1Division of Gastroenterology, Department of Medicine, Western University, London Health Sciences Center, London, Ontario, Canada.
Insights
Corticosteroids show survival benefits for severe alcohol-associated hepatitis (AH). Combination therapies may further improve outcomes, but evidence certainty is low to moderate, necessitating further research for optimal treatment strategies.
Area of Science:
- Hepatology
- Pharmacology
- Clinical Medicine
Background:
- Alcohol-associated hepatitis (AH) is a severe liver disease with high short-term mortality.
- Optimal pharmacological interventions for severe AH remain under investigation to improve survival rates.
Purpose of the Study:
- To systematically review randomized controlled trials (RCTs) evaluating medical therapies for severe AH.
- To determine the most effective pharmacological treatments for severe AH to enhance patient survival outcomes.
Main Methods:
- A systematic review of MEDLINE, EMBASE, and CENTRAL databases was conducted up to February 16, 2025.
- Included 52 RCTs involving 5121 adult participants with severe AH, analyzing mortality at 28 and 90 days, adverse events, and other clinical outcomes.
- Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated, with evidence certainty assessed using GRADE methodology.
Main Results:
- Corticosteroids demonstrated a survival benefit at 28 days compared to placebo (RR, 0.62; 95% CI, 0.41‒0.95).
- Combination therapies, including corticosteroids with N-acetylcysteine, granulocyte colony-stimulating factor plus pentoxifylline, and metadoxine with corticosteroids, showed significant survival advantages.
- The certainty of evidence for these findings ranged from very low to moderate.
Conclusions:
- Low certainty evidence supports corticosteroids as a first-line therapy for eligible severe AH patients.
- Evidence for other investigated therapies, while promising, is of low to moderate certainty.
- Further high-quality research is essential to confirm the benefits of these pharmacological interventions in severe AH.
Background & Aims:
Alcohol-associated hepatitis (AH) is a severe form of alcohol-associated liver disease, with a short-term mortality of up to 50% within 3 months. The aim of this systematic review was to determine the optimal pharmacological treatment for severe AH that results in better survival outcomes.
Methods:
MEDLINE, EMBASE, and CENTRAL were searched through February 16, 2025, for randomized controlled trials (RCTs) of medical therapy for adults with severe AH. The primary outcome was mortality at 28 days. Secondary outcomes included mortality at 90 days, adverse events, the incidence of hepatorenal syndrome, acute kidney injury or infections, and liver transplantation rates. Pooled risk ratios (RRs) and 95% confidence intervals (CIs) were calculated for each outcome. GRADE was used to assess certainty of evidence.
Results:
Fifty-two RCTs (5121 participants) were included in the review. A survival benefit at 28 days was observed for corticosteroids over placebo (RR, 0.62; 95% CI, 0.41‒0.95), for corticosteroids plus N-acetylcysteine over corticosteroids alone (RR, 0.35; 95% CI, 0.16‒0.78), for granulocyte colony-stimulating factor combined plus pentoxifylline over pentoxifylline alone (RR, 0.27; 95% CI, 0.13‒0.54), and metadoxine combined with corticosteroids over corticosteroids alone (RR, 0.47; 95% CI, 0.25‒0.90) or pentoxifylline (RR, 0.50; 95% CI, 0.26‒0.96). The certainty of evidence ranged from very low to moderate.
Conclusions:
Low certainty evidence supports the efficacy of corticosteroids as first line therapy for eligible patients with severe AH. The certainty of the evidence supporting other therapies ranges from low to moderate. Further studies are needed to confirm these benefits.
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